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This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.
Actinic keratoses (AK) are chronic skin changes usually induced by UV radiation. There are numerous options to treat AK. Some of the most used field-directed therapies include topical therapy with 5-fluorouracil (5-FU) cream and photodynamic therapy. However, the treatment with 5-FU is not without side effects (erythema, pruritus, itching/burning, etc.). Therefore, in daily clinical practice, cosmetic pre- and concomitant applications of cosmetics are often recommended to increase the efficacy as well as the tolerability of Tolak®.
The aim of this randomized, evaluator blinded, controlled parallel group study conducted in compliance with the 2013 version of the Declaration of Helsinki is to determine whether and how the application of cosmetics leads to an influence on the microbiome of AK.
Statistical method: The variables will be analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. Each test will be two-sided, at the 0.050 significance level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: holistic approach | Experimental | adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start |
|
| Group B: Tolak® Standard of use | Active Comparator | adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A: holistic approach | Other | 2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lesion response rate | It is defined as the number of completely responding lesions divided by the total number of treated lesions in each field. Complete lesion response is defined as complete disappearance of the lesion both by palpation and visual. | from baseline to Day70 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change | The lesion complete response rate is defined as the percentage of pre-existing and treated lesions at Baseline that are assessed as clear (complete disappearance of the lesion, visually and by palpation). | from baseline to Day70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Dirschka | Contact | +49 2 02 / 629337-32 | s.weber@centroderm.de |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Dirschka | CentroDerm GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CentroDerm GmbH | Recruiting | Wuppertal | Germany |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| Group B: Tolak® Standard of use | Other | 4-week Tolak® alone treatment (once daily in the evening) |
|
| D017437 |
| Skin and Connective Tissue Diseases |